Author: Peter

Avoiding pre-market verification is downright easy…Theranos isn’t alone in avoiding regulation using an easily exploited loophole — in fact, it’s just one among many…Pathway Genomics, Admera Health, and Strand Life Sciences are diagnostics companies that offer cancer tests that impact people’s health care decisions. None of these companies have published data about their tests in peer-reviewed journals. Nor were any of these companies required to show regulators that their tests worked before they started marketing them to patients and physicians. That’s because each of these companies has been making use of what's known as the "laboratory developed test" loophole — which makes avoiding pre-market verification downright easy...Under the LDT loophole, any company that develops and conducts a diagnostic test in their own lab…can avoid submitting that test to the FDA before using it on patients. This get-out-of-regulation-free card exists because research hospitals often modify commercial tests. In the case of these hospitals, the academic researchers tend to publish their results anyway…The FDA knows this — even they’ve been calling LDTs a loophole — and the agency wants to change the way these tests are regulated…until that loophole closes, we’ll keep seeing companies using the LDTs as a dodge, because it’s a simpler and cheaper way to get to market. The real expense, of course, is patients’ health.

Once a pharmacy has attracted a solid base of patients, the next step is keeping them coming…pharmacies can maintain a loyal community of patients…patients are on autopilot, so their habits may lead them to the same pharmacy every time. However, other patients may have medications filled at multiple pharmacies, and some of them may be looking for a home base…Here are 5 tips to keep patients loyal to your pharmacy:

1. Let patients know what you do, and tell your story
2. Implement an adherence program
3. Investigate your pharmacy’s challenges
4. Know your market
5. Find your niche

China has signaled a tougher stance on drug quality in the country’s sprawling pharmaceuticals industry by rejecting applications for 11 medicines with inadequate or suspect clinical data…China Food and Drug Administration said…that the move affected eight Chinese companies making generic drugs for heart problems, schizophrenia, pain, infections and other diseases…The crackdown follows a call in July for manufacturers to carry out their own internal investigations into trial data, which had already led to a number of voluntary recalls…The CFDA then carried out a series of on-site inspections…and discovered that clinical trial data in applications from eight companies for 11 drug products were incorrect or incomplete…“We have decided to withhold approval from these applications,”...

• Hainan Pharmaceutical
• Zhejiang Huahai Pharmaceutical
• Hebei Pharmaceutical
• Qingdao Bai Yang Pharmaceutical
• Zhejiang Angli Kang Pharmaceutical
• Hainan Kang Chi Pharmaceutical
• Guangdong Pharmaceutical
• Shandong Da Yinhai
  

…Americans overdose and die after taking opioid painkillers...people abuse or misuse the drugs…addictions and deaths mount…authorities are struggling to cope…State lawmakers are introducing bills to restrict prescribing…Food and Drug Administration is pushing pharmaceutical companies to develop more tamper-resistant products…the most sweeping initiative comes from the Centers for Disease Control and Prevention, which has prepared preliminary prescribing guidelines for primary care physicians…call on doctors to prescribe opioids only after other therapies have failed…there is considerable opposition to the guidelines…critics…say the CDC guideline process was flawed and, as a result, some patients will be denied much-needed pain relief.

When it comes to disclosing clinical trial data, some drug makers are still keeping secrets, according to a new study…Thirty-five percent of all trial results for 15 drugs that were approved in 2012 by the Food and Drug Administration were not publicly disclosed. And nearly 30 percent of the trials conducted for those drugs failed to meet legal disclosure requirements…“This confirms that pharmaceutical companies often fall below legal and ethical standards,”…The findings come amid growing clamor from academics and consumer groups to press drug and device makers to release trial data. If research is not published or reported in accessible registries, physicians and patients are prevented from having a complete picture of the risks and benefits of medicines…Such concerns have been heightened following various safety scandals that revealed trial data for some products was never fully published or disclosed. A few notable examples include…Vioxx.. and…Paxil…Over the past year, regulators in the US and Europe responded to concerns by releasing new rules designed to widen access. The World Health Organization has released a new position statement calling for companies to publish all research studies…Sense About Science, a UK nonprofit that launched the AllTrials campaign to widen access to data, is working with 85 asset managers and pension funds to assess steps taken by drug makers to provide trial information…

Report says small thefts may indicate syndicates are scoping out targets…Drugmakers have stepped up their game in recent years in protecting their supply chains against cargo theft. But thieves can be resourceful, and a big jump in losses in the third quarter indicates ways in which they have evolved their own techniques…In its Q3 report on U.S. cargo theft, FreightWatch International reported that while cargo thefts across all categories were down 18% and pharma thefts accounted for only 6% of total incidents, the numbers of cargo thefts in the drug industry increased a whopping 125% over the previous quarter and 350% over the same quarter a year ago…The industry continues to work with law enforcement to detect trends, and it has paid off with some arrests and convictions.

U.S. prosecutors plan to ask the Canadian and British governments to extradite officials with an online pharmacy on charges of smuggling $78 million worth of mislabeled, unapproved and counterfeit cancer drugs into the country to sell to doctors…Fourteen companies and individuals from Canada, the United Kingdom, Barbados and the U.S. are accused of participating in the conspiracy that involved falsifying customs declarations for shipments from the U.K., according to the criminal indictment…Winnipeg-based Canadadrugs.com and its CEO, Kristjan Thorkelson, are accused of spearheading the conspiracy, aided by a subsidiary in the U.K., River East Supplies Ltd., and two subsidiaries in Barbados, Rockley Ventures Ltd. and Global Drug Supply Ltd.

Media scrutiny of high drug costs…spending on drugs represents 10% of overall health care costs. Together, hospital and physician expenditures account for 6 times the spending on drugs. Despite a recent uptick in the rate of drug cost growth, over the past 10 years the pace of hospital and physician expenditures has exceeded prescription drugs…these facts do not make for eye-catching headlines. By contrast, the recent surge in the price of drugs targeting hepatitis C, HIV, and various cancer and orphan diseases, is salient and the focal point of media attention…Here, we unravel several mysteries surrounding drug pricing and alignment of price and value.

• Why is pricing in the U.S. different?
• How are drugs priced in the US?
• What about R&D and its relation to price?
• Then what?
• But, does price = value?
• What are the alternatives?
• Summary

A massive trade pact between 12 Pacific rim countries could limit the availability of affordable medicines, the head of the World Health Organization said…joining a heated debate on the impact of the deal…Margaret Chan told a conference there were “some very serious concerns” about the Trans-Pacific Partnership…trade policy which still needs to be ratified by member governments…“If these agreements open trade yet close the door to affordable medicines we have to ask the question: is this really progress at all,” Chan asked a conference in Geneva…The deal’s backers, including the United States, Canada, Japan and Australia, say it will cut trade barriers and set common standards across 40 percent of the world’s economy…But other bodies, including leaders of India’s $15 billion pharmaceuticals industry, have said it could end up protecting the patents of powerful drugs companies inside the deal area, at the expense of makers of cheaper generic drugs outside.

Elias Cachine, PharmD, BCPS (AQ-10), discusses the factors that can potentially contribute to antimicrobial overuse in geriatric patients.